Doxercalciferol Before Surgery in Treating Localized Prostate Cancer - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00022412

Purpose

RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.

PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: doxercalciferol Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Intermediate endpoint biomarker modulation [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Study Start Date:

August 2001

Detailed Description:

OBJECTIVES:

Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
Assess the toxicity of this drug in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 arms.

Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed localized adenocarcinoma of the prostate
Candidate for prostatectomy

PATIENT CHARACTERISTICS:

Age:

21 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

WBC at least 4,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.4 mg/dL
AST no greater than 3 times normal

Renal:

Creatinine no greater than 2.0 mg/dL
Calcium no greater than 10.2 mg/dL
No idiopathic urinary calcium stone disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

No prior hormonal therapy for prostate cancer
No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins

Radiotherapy:

No prior brachytherapy or external beam radiotherapy for prostate cancer

Surgery:

See Disease Characteristics

Other:

At least 7 days since prior vitamin D therapy or calcium supplements
No other concurrent vitamin D analogues or calcium supplements
No concurrent magnesium-containing antacids
No concurrent thiazide-containing diuretics
No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022412

Locations

United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226-3596
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Meriter Hospital
Madison, Wisconsin, United States, 53715

Sponsors and Collaborators

University of Wisconsin, Madison

National Cancer Institute (NCI)

Investigators

Study Chair:

George Wilding, MD

University of Wisconsin, Madison

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068813, WCCC-CO-99802, NCI-N01-CN-95130, WCCC-CO-2000169, NCI-P01-0188
Study First Received:	August 10, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00022412 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer

Study placed in the following topic categories:

1 alpha-hydroxyergocalciferol
Prostatic Diseases
Genital Neoplasms, Male
Vitamins
Bone Density Conservation Agents
Trace Elements

Urogenital Neoplasms
Micronutrients
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Hydroxycholecalciferols

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Neoplasms by Site
1 alpha-hydroxyergocalciferol
Vitamins
Micronutrients
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009